Randox Laboratories Ltd.: Medical Device Recall in 2023 - (Recall #: Z-2609-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

Product Classification:

Class II

Date Initiated: August 3, 2023

Date Posted: September 27, 2023

Recall Number: Z-2609-2023

Event ID: 92912

Reason for Recall:

there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.

Status: Ongoing

Product Quantity: 66 kits

Code Information:

UDI-DI: 05055273208986; Lot Number: 1308UE

Distribution Pattern:

US States: GA, OH, OR, PA, TX, VA

Voluntary or Mandated:

Voluntary: Firm initiated